Comparison of the effect of ketamine and midazolam with morphine on the rate of depressive and anxiety disorders and PTSD in mechanically ventilated patients in the intensive care unit
Determining the effect of ketamine on the rate of depressive, anxiety and PTSD disorders after discharge from ICU
Design
Clinical trial with control group, block randomization, Fourty seven patients in each group with parallel groups, double blinded.
Settings and conduct
The study population is patients admitted to the ICU of 5 Azar Hospital in 1399. A total of 94 people were selected as available and assigned to the two groups receiving ketamine and midazolam with morphine using four-block random allocation. Patients after ICU discharge if the Glasgow Coma Scale (GCS) is greater than or equal to 14 are included in the study and HADS and PTSD questionnaires are administered by telephone at two weeks, two months later and six months later.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients should be mechanically ventilated in the ICU for at least 48 hours، Measurement Acute Physiology and Chronic Health Evaluation II Upon entering the ICU، Age range 18-60 years؛ Exclusion criteria: Patients due to drug poisoning، Patients due to suicide، Patients after، cardiopulmonary resuscitation Post CPR، Patients with a history of brain dementia and Alzheimer's، Patients with extensive cerebral hemorrhage، Patients with GCS = 3 at the time of admission to the ICU، Patients with a history of taking neurological drugs
Intervention groups
Intervention group: The ketamine group is infused at a dose of 0.5 mg / kg for 15 minutes, followed by an intravenous infusion of 0.5 µ/kg/h. Control group: Midazolam at 3-5mg / h and morphine at 2-3mg / h.
Main outcome variables
The rate of depressive disorders, anxiety and PTSD.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170413033408N5
Registration date:2021-02-07, 1399/11/19
Registration timing:prospective
Last update:2021-02-07, 1399/11/19
Update count:0
Registration date
2021-02-07, 1399/11/19
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3254 9891
Email address
dr.mojaveraghili@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of ketamine and midazolam with morphine on the rate of depressive and anxiety disorders and PTSD in mechanically ventilated patients in the intensive care unit
Public title
Determining the effect of ketamine on the rate of depressive, anxiety and PTSD disorders after discharge from ICU
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients should be mechanically ventilated in the ICU for at least 48 hours.
Measurement Acute Physiology and Chronic Health Evaluation II Upon entering the ICU
Age range 18-60 years
Exclusion criteria:
Patients due to drug poisoning
Patients due to suicide
Patients after cardiopulmonary resuscitation Post CPR
Patients with a history of brain dementia and Alzheimer's
Patients with extensive cerebral hemorrhage
Patients with GCS = 3 at the time of admission to the ICU
Patients with a history of taking neurological drugs
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be assigned to the groups receiving ketamine and midazolam in a four-block.Therefore, we will have 6 blocks in which the order of allocating samples in groups is (AABB-ABAB-ABBA-BAAB-BABA-BBAA) and each of the blocks is assigned numbers from 1 to 6 and randomly from 1 to 6 Select a number and select the block corresponding to the desired number and assign the patients to the two groups according to the block.
Blinding (investigator's opinion)
Double blinded
Blinding description
Assignment of samples to groups is done by a specialist physician so that it is not possible for the physician to blind. Patients are unaware that they are assigned to the ketamine and midazolam groups. In addition, the psychiatrist will be unaware of how patients are assigned to the groups during data collection during the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
Street address
Gorgan, 4 km, Sari, Golestan University of Medical Sciences, Gorgan, Iran. Deputy of Research and Technology of Gorgan, Golestan, Iran
City
Gorgan
Province
Golestan
Postal code
49341-74515
Approval date
2020-11-15, 1399/08/25
Ethics committee reference number
IR.GOUMS.REC.1399.318
Health conditions studied
1
Description of health condition studied
depressive and anxiety disorders
ICD-10 code
F41.2
ICD-10 code description
Mixed anxiety and depressive disorder
2
Description of health condition studied
Post traumatic stress disorder
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder (PTSD)
Primary outcomes
1
Description
The rate of depressive disorders
Timepoint
Mean score of depressive disorders during two weeks, two months and six months after discharge.
Method of measurement
The first interview was conducted two weeks later and the next interview was conducted two months later and six months later by telephone using Beck Depression questionnaire.
2
Description
Anxiety Disorders
Timepoint
Mean score of anxiety disorders during two weeks, two months and six months after discharge.
Method of measurement
The first interview was conducted two weeks later and the next interview was conducted two months later and six months later by telephone using the Beck Anxiety questionnaire.
3
Description
PTSD Disorders
Timepoint
Mean score of PTSD disorders during two weeks, two months and six months after discharge.
Method of measurement
The first interview was conducted two weeks later and the next interview two months later and six months later by telephone using the PCI questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The ketamine group is infused at a dose of 0.5 mg / kg for 15 minutes, followed by an intravenous infusion of 0.5 µ/kg/h.
Category
Treatment - Drugs
2
Description
Control group: Midazolam at 3-5mg / h and morphine at 2-3mg / h.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gorgan 5 Azar Educational and Medical Center
Full name of responsible person
Dr.Babak mojaver aghili
Street address
Gorgan-Sari road 4th kilometers, Golestan University of Medical Sciences, School of Medicine - Anesthesiology Department
City
Gorgan
Province
Golestan
Postal code
2534756984
Phone
+98 17 3334 2067
Email
dr.mojaveraghili@goums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Honarvar
Street address
Golestan University of Medical Sciences, Deputy of research and technology-Gorgan-Gorgan-Sari 4th kilometer,
City
Gorgan
Province
Golestan
Postal code
4917763681
Phone
+98 17 3115 3566
Fax
+98 17 3245 1657
Email
Honarvar@gous.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
dr Babak Mojaver Aghilli
Position
Anesthesiologist, Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Golestan University of Medical Sciences.School of Medicine, Department of Anesthesiology, Gorgan, Shastkola road
City
Gorgan
Province
Golestan
Postal code
4917763681
Phone
+98 17 3115 3566
Email
drbabaka35@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Seyed babak Mojaveraghili
Position
Assistant Professor - Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Medical school, anesthesia group, Gorgan - Sari 4th kilometers
City
Gorgan
Province
Golestan
Postal code
491776381
Phone
+98 17 3115 2566
Fax
+98 17 3232 6072
Email
dr.mojaveraghili@goums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
ُSeyed Babak Mojaver Aghili
Position
Assistant Professor - Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Medical school, anesthesia department,Gorgan-Sari raod 4th kilometers
City
Gorgan
Province
Golestan
Postal code
491776381
Phone
+98 17 3115 3566
Fax
+98 17 3232 6072
Email
dr.mojaveraghili@goums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the main outcome
When the data will become available and for how long
Since 2021
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
No manipulation, mentioning the data reference
From where data/document is obtainable
Seyed Babak Mojaver Aghili, drbabaka35@gmail.com, Golestan University of Medical Sciences, Deputy of Research and Technology, Gorgan, Golestan, Iran, Gorgan, 4 km, Sari,
What processes are involved for a request to access data/document
sending an email, complete the personal and professional characteristics with documentation